SOPHIA ANTIPOLIS, France – September 12, 2022 │ KnowMade recaps and details key patent information in Moderna’s lawsuit against Pfizer BioNTech, regarding the mRNA technology used in their COVID-19 vaccines.
Patent infringement battles start
Since the COVID-19 pandemic appears to be under control, companies developing mRNA are starting to enforce their IP rights. Among the current patent infringement actions, we can mention CureVac’s action against BioNTech, which our expertise in patent analysis had foreseen in early 2021 (read our article indicating CureVac’s patent leadership position); Alnylam’s action against Moderna and Pfizer; and the most recent, Moderna filing patent infringement lawsuits against Pfizer and BioNTech in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany. According to Moderna, patents related to this action are central to the innovative Moderna mRNA technology platform. Let’s get inside these patents, their protection and Moderna’s related patents.
US patent for mRNA vaccine engaged in Moderna vs Pfizer & BioNTech battle
On Friday August 26, 2022, Moderna announced that it was suing Pfizer BioNTech for patent infringement concerning the Comirnaty® RNA vaccine. The action was brought before a US court and a German court. In front of the US court, the asserted patents are US10898574 (‘574), US10702600 (‘600) and US10933127 (‘127). According to Moderna’s CEO, these patents cover the Moderna mRNA platform technology. In short, these patents cover mRNA modifications (‘574), encoded sequences (‘600) and the combination of mRNA and lipidic nanoparticle (LNP) carrier. The main characteristics of these patents are summarized below:
- Patent ’574 claims mRNA encoding for a polypeptide that comprises a modified uracil, including 1-methylpseudouridine, in a lipid nanoparticle formulation. Patent ’574 claims both methods of producing a polypeptide of interest and pharmaceutical compositions.
- Patent ’600 claims compositions comprising mRNA with an open reading frame (ORF) encoding a beta-coronavirus S protein or S protein subunit formulated in a lipid nanoparticle.
- Patent ’127 claims methods of administering mRNA comprising an ORF encoding a beta-coronavirus S protein or S protein subunit formulated in LNP to induce in the subject an immune response to the S protein or S protein subunit, wherein the LNP comprises certain specified percentages of ionizable cationic lipid, neutral lipid, cholesterol, and PEG-modified lipid.
According to Moderna’s complaint, the BioNTech and Pfizer mRNA COVID-19 vaccine (Comirnaty®) constitutes a material part of inventions claimed in patents ‘574, ’600 and ‘127. Infringement arguments are based on the package insert for Comirnaty® (sections 11 and 12) and the defendant’s own publication (Vogel et al., Nature, 2021). In detail, Moderna’s arguments are:
- Section 12 of the package insert for Comirnaty® states that “the nucleoside-modified mRNA in Comirnaty® is formulated in lipid particles, which enable delivery of the mRNA into host cells to allow expression of the SARS-CoV-2 S antigen”, and Vogel et al., Nature, 2021 confirms that the uridines in Comirnaty® are modified uridines (1-methylpseudouridine). Based on this information, it seems that Comirnaty® may constitute a material part of the invention claimed in patent ’574.
- Section 11 of the package insert for Comirnaty® further states that “each 0.3 mL dose of Comirnaty® contains 30 mg of a nucleoside-modified mRNA encoding the viral spike (S) glycoprotein”, which is a beta-coronavirus S protein. Based on this information, it is likely that Comirnaty® constitutes a material part of the invention claimed in patent ’600.
- Section 11 of the package insert for Comirnaty® states that “each 0.3 mL dose of the Comirnaty® also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose”. Regarding the detailed composition, it seems that this lipid nanoparticle composition falls within the ranges specified in the claims of patent ’127.
European patent for mRNA vaccine engaged in Moderna vs Pfizer & BioNTech battle
In addition to the US litigation, Moderna has also filed a patent infringement suit against Pfizer and BioNTech at the Regional Court of Düsseldorf (Germany). In front of this jurisdiction, the asserted patents are EP3590949 (‘949) and EP3718565 (‘565), both recently granted (April and March 2022 respectively) in all EPO designated states and are still in the opposition period. The main characteristics of these patents are summarized below:
- Patent ’949 claims a polypeptide wherein 100% of nucleotide comprising uracil are replaced with nucleotide comprising 1-methylpseudouridine. Patent ’949 claims both methods of producing a polypeptide of interest and mRNA of the invention.
- Patent ‘565 claims a beta-coronavirus mRNA vaccine encoding a spike (S) protein and formulated in a lipid nanoparticle comprising certain specified percentages (comprised in range claimed in ‘127) of ionizable cationic lipid, neutral lipid, cholesterol, and PEG-modified lipid.
The German lawsuit is not public for now but a hypothesis can be made on the basis of the US complaint and European patent description. Indeed, the European patent protections are similar on the LNP formulation and the encoded antigen (protein S). Even if patent 949’ claims a 100% replacement by modified nucleotide which is more specific than in patent ‘574, infringement arguments developed in the US complaint and based on the package insert for Comirnaty® (section 11 and 12) and the Pfizer & BioNTech publication might also be developed in the German case (the publication described a 100% uracil replacement by N1-methylpseudouridine-5′-triphosphate).
BioNTech responded to the lawsuits, claiming that Comirnaty® came from original work. Moreover, in a statement, the company says it “remains confident in its intellectual property”, without commenting on its legal strategy to fight back against Moderna’s action. As Moderna’s European patents are still in the opposition period, this procedure cannot be excluded as a Pfizer/BioNTech fightback strategy. Indeed, Pfizer/BioNTech already filed an opposition against two European patents from Moderna (EP3682905 and EP3492109), both related to modified nucleoside to improve mRNA stability.
Today, we are witnessing the beginning of litigation regarding mRNA treatments. However, these patent infringement procedures should multiply in the next few years, as several products will be launched using mRNA therapeutics as treatments against various pathologies (infectious diseases, cancer, or gene therapy).
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About the author
Elodie Bovier works at KnowMade as a Patent Analyst in the field of Biotechnology and Life Sciences. She holds a PhD in genetic and molecular biology from Paris Sud University. She also holds an Industrial Property International Studies Diploma (in Patent and Trademark & Design Law) from the CEIPI (Strasbourg, France).
Fabienne Massa works at KnowMade in the field of Biotechnology and Life Sciences. She holds a PhD in Molecular and Cellular Biology from the IPMC (Nice, France). She also holds a Master of Business Management from IAE (Nice, France) and she previously worked in the pharmaceutical industry.
KnowMade is a Technology Intelligence and IP Strategy consulting company specialized in analysis of patents and scientific information. The company helps innovative companies and R&D organizations to understand their competitive landscape, follow technology trends, and find out opportunities and threats in terms of technology and patents.
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